Orthopedic braces are generally categorized as precision medical appliances, designed to be assistive devices for disabled people. Many types of braces exist for different applications. Generally prescribed by a doctor and built by an orthotist, the brace is built to solve a specific medical problem. Problems such as longevity and integrity of the human joint(s), compensation of limb length differences, etc. are addressed, but very often the function of a brace as it pertains to the medical condition is the primary focus. Therefore, the design of the brace may not take into consideration the user or patient in terms of user convenience, comfort, aesthetics, or component quality and durability. Often, the user has few or no options, other than to wear the brace or not wear it. The overall design and concept of the metallic orthopedic brace has not substantially changed in fifty years.
Design, quality and fit are keys to the proper operation and function of a brace. When any one of these is inadequate, the brace will not be useful or comfortable to the user. However, the brace must still be used regardless of fit or comfort because it is necessary for the medical needs of the user. Further, as the brace components wear, the originally provided support is greatly reduced, and the fit becomes worse. The result to the user can be pressure sores, ulcers or break down of the limb. These sores or ulcers can be very serious and can severely affect the health and lifestyle of the patient. Patients that must wear an orthopedic appliance may not have feeling in the particular limb, and the awareness of a problem; sores, infections, etc. is not realized until the brace is removed, generally at the end of the day.
The standard design of the orthopedic ankle brace (described in more detail below) includes a stirrup mounted in the sole of a shoe. The stirrup then is fastened via screws to the upper portion of the brace. This standard design of the orthopedic ankle brace does not allow the user to easily remove the shoe/stirrup from the brace. Typically, problems such as ulcers or open sores can occur in the foot-ankle area where constant relative motion or rubbing occurs between the foot and shoe due to rubbing during use.
Although orthopedic shoes are generally "cast" to the foot, enough clearance (caused by temperature swelling of the foot and/or shoes) still exists for abrasive "rubbing". When the user's medical condition is a fused ankle, little or no ankle movement or rotation of the foot can occur. When the patient wears the brace, every step causes rotation between the shoe/stirrup and the brace, creating the relative movement or "rubbing" between the foot and shoe. When the brace components are new, the rotational movement which causes the rubbing may be slight, but as the joint components quickly wear the movement problem is magnified and the "rubbing" action becomes excessive.
The standard design for fastening the shoe to the brace is simply a screw or locknut or T-nut coupling the brace to the shoe/stirrup (see prior art FIGS. 1 and 2). The stirrup is installed within the shoe sole and becomes an integral part of the shoe. This fastening method is standard within the orthopedic industry and allows component interchangeability between the various manufacturers.
This standardization leaves little flexibility for the user, making it extremely difficult (almost impossible for the user while wearing the brace) to readily remove the shoe as a convenience option, or more importantly to check the foot for ulcers, or other potential problems. Proper operation of a screwdriver is impossible at the position and angle required when wearing the brace and the user chances the screwdriver slipping from the screw into the foot. Equally difficult is the insertion and removal of the nut while trying to insert and align the stirrup and upright member of the brace.
FIG. 1 is a partial cross sectional view which illustrates the standard fixed ankle brace/shoe relationship and how the "rubbing" occurs. FIG. 2a shows the prior art shoe and brace in the standing upright position or a relative position of ninety degrees. FIG. 2b shows the undesired rotation of the prior art brace joint as the user takes a normal stride. Due to the nature of this standard design, the T-nut and screw create a fulcrum to the body's mass and the shoe rotation occurs around this pivot point. Due to the flexibility of the human body, the brace, even when properly secured, is not a rigid part of the leg, and any excess "play" between the leg and brace will generate problems. As the rotation progresses (FIG. 2b), the upright of the brace is no longer parallel to the user's leg.
FIG. 2b also illustrates how the rotation occurs perpendicular to the joint, and the movement is limited only by the upper corner of the brace slot. The result is point contact between the stirrup and the upright which generates excessively high stresses at the upper corner of the stirrup slot. These high stresses promote accelerated component wear and harmful rotation, and quickly increase the potential of undesired "rubbing". For a fixed ankle patient, it is very important that the brace pivot (screw and T-nut) be exactly in line with the patient's ankle joint. If not, the rotation that does occur will be around more than one point, and may cause more problems.
Another major problem of this standard design is, as the components wear, the structural integrity of the brace diminishes. This often leads to problems such as the user falling or tripping due to the instability of the brace and shoe. Such a situation can cause the user to further suffer from sprains or even broken bones.
There have been attempts made to solve some of the above mentioned problems. For example, U.S. Pat. No. 3,064,644 issued to Patterson on Mar. 2, 1960 discloses a lower leg brace designed to aid the user in "toe pickup". As the user takes a step, the secondary hardware (springs, balls and push rods) generate a force greater than the weight of the foot and assist the foot and ankle into position for the next step. One object of Patterson is to be able to remove the stirrup from the leg brace. The insertion process requires the solid tongue (items 6 and 8) to slide into the stirrup and lock into position. The secondary spring and rod pressure helps to hold the tongue within the stirrup. In order for the tongue to be inserted in the stirrup, an insertion angle requiring a large dimensional difference between the tongue and stirrup must exist (FIG. 3). The resulting "play" within these parts results in unwanted movement between the shoe and brace as described earlier. Secondary screws, springs, balls and rods are required to complete this assembly. The end product is heavy, bulky and not "self contained" unlike the present invention. The present invention is much more compact, uses geometry for a precision fit, and uses the inert properties of the metal to create the spring required to connect and disconnect the shoe and stirrup. The present invention requires no secondary hardware as does the Patterson device.
U.S. Pat. No. 2,934,064 issued to Invidiato on Apr. 13, 1954 discloses a surgical brace intended to fit within the shoe of a user. Invidiato does not disclose the brace being connected to, or quickly released from, the shoe. The present invention is designed to be attached to, and quickly released from, the user's shoe.
U.S. Pat. No. 874,446 issued to Slater on Jan. 21, 1907 discloses a brace wherein a wing nut is used to secure the brace to the stirrup. This device is intended to be a surgical splint and has no similarity to the present invention.
U.S. Pat. No. 4,646,726 issued to Westin, et al. on Nov. 6, 1985 discloses an ankle joint strap orthosis and is not a brace-shoe device unlike the present invention. Westin, et al.'s orthosis has no similarity to the present invention.
U.S. Pat. No. 3,454,002 issued to Westlake, et al. on Feb. 28, 1966 discloses an orthopedic splint and has no similarity to the present invention.
U.S. Pat. No. 2,516,872 issued to Hauser. et al. on Jan. 27, 1948 discloses a brace wherein the wearer may change his shoes without removing the brace from his leg. The design of the Hauser, et al. brace requires the use of secondary components to achieve the disconnecting function. One side of the Hauser, et al. brace uses a guide pin which slides into the stirrup and is retained by a pivoting arm that is screwed to and pivots from the upright portion of the assembly. The release mechanism is a lever located on the opposite side of the brace. The lever (25), which is pivoted from the upright, slides into a recessed area of the stirrup after insertion. The forces are transferred entirely through the opposite pin and slide since the locking lever has no means to retain it in the locked position. The forces on the brace would tend to open the lever as the user takes a normal stride. This is especially true when the parts begin to wear. Further, the connect and disconnect process is almost as difficult as the shoe removal from a standard brace. The Hauser, et al. device is bulky, requires many parts, is not self contained and the parts are not interchangeable to either side of the shoe or brace.
The present invention solves the problems and shortcomings of the above mentioned prior art devices.